New Study Shows Screening Based on Self-Reported Ethnicity Fails to Identify Significant Percentage of Pregnancies Affected by Serious Genetic Conditions
SALT LAKE CITY, Aug. 10, 2020 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and precision medicine, announced today a new study published in the peer-reviewed journal Genetics in Medicine demonstrates the limitations of ethnicity-based medical guidelines in identifying couples at risk for a pregnancy affected by serious genetic conditions. The analysis of 93,419 individuals found substantial discordance between self-reported ethnicity and actual genetic ancestry.
In the new study, researchers at Myriad assessed the ability of a 96-disease screen to identify carriers in an ethnically diverse population, comparing the results to those obtainable via ethnicity-based screening. They also compared the genetic ancestry of the population to self-reported ethnicity. Results showed that only 23 percent of carriers would have been identified through ethnicity-based screening protocols supported by societal guidelines. Further, for seven of the 16 diseases included in the guidelines, most carriers were not from the populations that the American College of Obstetricians and Gynecologists (ACOG) and the American College of Medical Genetics and Genomics (ACMG) have indicated were at higher risk of the respective genetic disorders.
“Due to changing demographics and increased intergroup marriage, the risk of passing along genetic diseases is no longer concentrated in specific ethnicities,” said lead researcher Dale Muzzey, Ph.D., vice president of bioinformatics at Myriad Genetics. “At the same time, a large proportion of patients cannot accurately identify the ethnicities of their ancestors. Combined, these factors point to the need for more efficient and equitable carrier screening for a comprehensive list of genetic disorders.”
In the past decade, the evolution of carrier screening methodology has enabled scalable screening of many serious single-gene diseases simultaneously, termed expanded carrier screening (ECS). Although panethnic ECS, as offered to all patients without regard to ethnicity, has established analytical validity, clinical validity, clinical utility, and cost-effectiveness, both ACOG and ACMG currently stop short of recommending that ECS be preferentially offered. Instead, screening based on self-reported ethnicity continues to be endorsed as a standard.
“Offering expanded carrier screening to all patients who are pregnant or considering pregnancy, regardless of their self-reported ethnicity, better identifies carriers and more important, at-risk carrier couples, while avoiding the complexities and disparities created by ethnicity-based screening guidelines,” said James Goldberg, MD, board-certified maternal fetal medicine specialist, medical geneticist, and chief medical officer, Myriad Women’s Health.
Carrier screening identifies pregnancies at increased risk of serious genetic conditions that may reduce lifespan, result in intellectual disability or that would benefit from prenatal or perinatal intervention. Carrier screening is typically performed by first identifying females who are carriers for autosomal recessive or X-linked conditions, and subsequently testing their reproductive partners for those same conditions. Under current guidelines from ACOG and ACMG, only cystic fibrosis and spinal muscular atrophy carrier screening should be offered to all who are pregnant or considering pregnancy, and screening for a small number of additional conditions should be offered only in those who self-report and are based upon ethnicity.
About Myriad Foresight® Carrier Screen
Myriad Foresight Carrier Screen is a genetic test that identifies couples who are at increased risk of passing on inherited conditions to their children. Foresight tests for more than 175 serious and clinically-actionable conditions. It is estimated that serious genetic conditions affect one in 300 pregnancies. For more information, visit: https://myriadwomenshealth.com/provider-foresight/
About Myriad Genetics
Myriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on three strategic imperatives: transitioning and expanding its hereditary cancer testing markets, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company's website: www.myriad.com.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice CDx, Vectra, Prequel, Foresight, GeneSight, riskScore and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G.
Safe Harbor Statement
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related the Company’s new study published in the peer-reviewed journal Genetics in Medicine; and the Company’s strategic directives under the caption "About Myriad Genetics." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: uncertainties associated with COVID-19, including its possible effects on our operations and the demand for our products and services; our ability to efficiently and flexibly manage our business amid uncertainties related to COVID-19; the risk that sales and profit margins of our molecular diagnostic tests and pharmaceutical and clinical services may decline; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to decisions or changes in governmental or private insurers’ reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests and services are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities and our healthcare clinic; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decisions in Mayo Collab. Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014); risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements; the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading "Risk Factors" contained in Item 1A of our most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2019, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.
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